Senior Manager, GMP Logistics Systems & Automation

The Senior Manager, GMP Logistics Systems and Automation – Automated Warehouse will lead the strategic development, validation, and lifecycle management of logistics systems and mechanical automated warehouse technologies across Global Logistics operations. Ensure end-to-end compliance for warehousing, material flow, and data integrity while delivering safe, efficient, and audit-ready operations integrated with Oracle-based platforms and related enterprise systems.

As a Senior Manager, a typical day might include the following:

• Serve as a key leader for the design, qualification, and continuous improvement of logistics systems, with emphasis on mechanical automated warehouse equipment and Oracle-based WMS/WES/TMS platforms.
• Own GxP compliance for warehouse systems and processes, aligning with GMP/GDP, GAMP 5 guidance, 21 CFR Part 11/EU Annex 11 for computerized systems, and Annex 15 for qualification.
• Oversee automation projects and ongoing performance of material handling systems to improve throughput, accuracy, and safety while maintaining validated state and robust change control.
• Ensure maintenance of appropriate data integrity controls (ALCOA+), including secure access, audit trails, backup/restore, disaster recovery, and cybersecurity considerations across IT/OT boundaries.
• Ensure GDP-compliant receiving, storage, and distribution processes, including environmental monitoring, temperature mapping, calibration/maintenance, and controlled material flows for sensitive products.
• Lead a cross-functional continuous improvement program that integrates quality-by-design, Lean/Six Sigma, and ICH Q9 risk management principles without compromising validated state.
• Develop and maintain GxP documentation: SOPs, work instructions, validation packages, training curricula, user manuals, and change control records; ensure training completion and effectiveness.
• Partner with Quality, IT, Engineering, EHS, and vendors to troubleshoot, enhance, and sustain system functionality; establish and manage supplier quality expectations and quality agreements.
• Own change control for system and automation upgrades, ensuring impact assessments, validation plans, execution, and release approvals are completed per QMS requirements.
• Monitor and report operational and quality KPIs (e.g., order accuracy, system uptime, deviation/CAPA trends, audit findings, on-time training).
• Provide leadership, coaching, and development to direct reports and project teams, building GxP and automation competencies across global sites.
• Perform other logistics-related tasks as needed to support business continuity and compliance objectives.

This role may be for you if you have:

• Deep understanding of logistics systems architecture and integration, especially Oracle-based platforms and interfaces to WES/WCS/PLC/SCADA.
• Working knowledge of mechanical automated warehouse systems and their maintenance in a validated state, including calibration, PM/CM, and spare parts strategies.
• Strong command of GxP frameworks: GMP/GDP/GEP, GAMP 5, 21 CFR Part 11, EU Annex 11, Annex 15, and ICH Q9 risk management; practical application of ALCOA+ data integrity.
• Strong project management skills for cross-functional initiatives in fast-paced, multi-site environments; ability to balance operational reliability with improvement.
• Excellent analytical and problem-solving skills; comfort with data analysis, dashboards, and reporting for operational and quality metrics.
• Effective communication and stakeholder management skills across Quality, IT, Operations, Engineering, and external vendors.
• Familiarity with emerging logistics automation technologies (robotics, IoT, AI/ML for predictive maintenance) and cybersecurity considerations for OT/IT convergence.
• Proficiency with Microsoft applications (Excel, Teams, SharePoint) and standard productivity tools.
• Ability to manage multiple priorities, contribute as a collaborative team member, and facilitate meetings and trainings in a global setting.

In order to be considered for this position, you must hold a Bachelor’s degree in Supply Chain Management, Logistics, Engineering, or related field and

• Manager: 7 years of experience in logistics, supply chain systems, or operations management.
• Senior Manager: 8 years of experience in logistics, supply chain systems, or operations management.
• Preferred degrees & certifications: Advanced Degrees, Project Management Professional (PMP), APICS.
• Experience in regulated industries, preferably life sciences or similar environments.
• May consider an equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.  

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$108,000.00 - $206,100.00